Promoting Sustainable Return to Work Among Employees on Sick Leave Due to a Mental Health Condition: Evaluation of the HealthyMinds Online Group Intervention

Not Applicable

Recruiting

• Conditions: Adjustment Disorder With Depressed Mood; Depression Anxiety Disorder; Adjustment Disorder With Anxious Mood; Adjustment Disorders
• Interventions: Behavioral: Healthy Minds

• Registration Number: NCT05963308
• Lead Sponsor: Université du Québec a Montréal

Brief Summary

The purpose of this clinical trial is to evaluate the impact of an online group intervention called Healthy Minds in facilitating a sustainable return to work for individuals with a mood disorder. The study aims to answer the following key questions :

* Does receiving the Healthy Minds online intervention lead to a more sustainable return to work compared to not receiving the intervention?

* Are the health outcomes (e.g., depressive symptoms) and work-related outcomes (e.g., work functioning) of individuals who receive the Healthy Minds online intervention better than those who do not receive the intervention in the year following the intervention?

Both experimental and control participants will be recruited at baseline while on sick leave (expected to return to work in less than one month) or recently returned to work (less than one month). Participants will complete a series of online questionnaires at the following time points :

* Baseline

* First follow-up (2 months after baseline)

* Second follow-up (6 months after baseline)

* Third follow-up (12 months after baseline)

The questionnaires will cover the following areas :

* Sociodemographic and biopsychosocial factors

* Symptoms associated with the primary mood disorder

* Cognitive difficulties and biaises

* Self-efficacy related to return to work

* Work accommodations and natural supports

* Relationship with immediate supervisor

* Work functioning

* Return to work time (number of days away from work)

Experimental participants will participate in the 2-month online Healthy Minds group intervention (cohort of 5 participants) between the baseline assessment and the first follow-up. The intervention consists of 8 sessions (one per week for 8 weeks), with each session focusing on a specific aspect of the return-to-work process from a cognitive-behavioral perspective.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-06
• Study First Submitted: 2023-07-18
• Study First Submitted QC: 2023-07-18
• Study First Posted: 2023-07-27
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-01
• Last Update Posted: 2024-05-03
• Primary Completion: 2025-03-01
• Study Completion: 2025-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Be in the process of returning to work after depression, anxiety disorder, adjustment disorder (with depressed mood, or anxious mood).

or

• Been back for less than a month

Exclusion Criteria

• Inability to communicate in French
• Have a known organic disorder
• Have already received CBT-type intervention (group or individual)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Online group intervention "Healthy Minds"	Healthy Minds	-

Primary Outcome Measures

Name	Time	Method
Sustainable return-to-work	Baseline; follow-ups at six months and 12 months	The number of days of job retention after returning to work
Relationship with immediate supervisor	Follow-ups at six months and 12 months	Inventory of perceptions of supervisory style at work
Depressive symptoms	Baseline; follow-ups at two months, six months and 12 months	Patient Health Questionnaire for depression (PHQ-9)
Return to Work Obstacles and Self-Efficacy	Baseline ; Follow-ups at two months	Return to Work Obstacles and Self-Efficacy Scale (ROSES)
Work functioning	Follow-ups at six months and 12 months	Endicott Work Productivity Scale (EWPS)
Cognitive difficulties	Baseline ; Follow-ups at two months, six months and 12 months	Online Stroop test (French version)
Anxiety symptoms	Baseline ; follow-ups at two months, six months and 12 months	Generalized Anxiety Disorder Scale (GAD-7)
Work accommodations	Follow-ups at six months and 12 months	The Work Accommodation and Natural Support Scale (WANSS).
Cognitive biases	Baseline ; Follow-ups at two months, six months and 12 months	Davos Assessment of the Cognitive Biases Scale

Trial Locations

Locations (1)

Université du Québec à Montréal; 🇨🇦 Montréal, Quebec, Canada